TY - JOUR
T1 - A Practical Approach to Risk-Benefit Estimation in Pediatric Drug Research
AU - Koren, Gideon
N1 - Publisher Copyright:
© 2014, Springer International Publishing Switzerland.
PY - 2014/2
Y1 - 2014/2
N2 - One of the most difficult challenges in pediatric drug research is in exposing children to risk, often without a balanced chance of benefits. While the concept of risk is similar in adult research, the adult patient can decide for himself/herself on an acceptable level of risk, whereas children have to accept the decisions of their guardians. This paper attempts to put the complexities of estimating risk in pediatric drug research into their practical perspective, and to familiarize the reader with the way such processes are conducted in different parts of the world. Although there are regional differences, all authorities typically quantify risks of pediatric research in general, and drug research in particular, in three levels: those experienced in day-to-day life; risks slightly above this ‘baseline’ risk; and risks substantially above ‘baseline risk’. Proportionally, the diligence of the ethics process depends on these levels, as well as on the potential benefits (or lack of) to the child involved in the research. Importantly, risk is context dependent, and a particular intervention may be effective or safe in one setting but not in another, based on local experience, staffing levels, and similar variabilities.
AB - One of the most difficult challenges in pediatric drug research is in exposing children to risk, often without a balanced chance of benefits. While the concept of risk is similar in adult research, the adult patient can decide for himself/herself on an acceptable level of risk, whereas children have to accept the decisions of their guardians. This paper attempts to put the complexities of estimating risk in pediatric drug research into their practical perspective, and to familiarize the reader with the way such processes are conducted in different parts of the world. Although there are regional differences, all authorities typically quantify risks of pediatric research in general, and drug research in particular, in three levels: those experienced in day-to-day life; risks slightly above this ‘baseline’ risk; and risks substantially above ‘baseline risk’. Proportionally, the diligence of the ethics process depends on these levels, as well as on the potential benefits (or lack of) to the child involved in the research. Importantly, risk is context dependent, and a particular intervention may be effective or safe in one setting but not in another, based on local experience, staffing levels, and similar variabilities.
UR - http://www.scopus.com/inward/record.url?scp=84921882802&partnerID=8YFLogxK
U2 - 10.1007/s40272-014-0100-6
DO - 10.1007/s40272-014-0100-6
M3 - ???researchoutput.researchoutputtypes.contributiontojournal.article???
C2 - 25408294
AN - SCOPUS:84921882802
SN - 1174-5878
VL - 17
SP - 13
EP - 16
JO - Paediatric Drugs
JF - Paediatric Drugs
IS - 1
ER -